LuitBiz

How Can LuitBiz Help A Regulatory Department Head?

• Product Registration: Manage product registration data and changes globally
• Product Submissions: Plan, track, author, review, and approve submission documents
• Approvals & Publishing: Enable continuous publishing and speed time to submission.
• Submission Archive: Securely view your complete submissions history in LuitBiz.
• Stay Inspection Ready: Ensure a constant state of inspection readiness by managing all TMF documents and processes in the same system.
• Streamline Collaboration: Provide study teams a real-time view of TMF completeness to help sponsors, CROs, and sites work together to accelerate trials.

Regulatory head officers ensure that products such as cosmetics, pharmaceuticals, and veterinary medicines meet legislative requirements. They need to study scientific and legal documents. gather, evaluate, organise, manage and collate information in a variety of formats to provide strategic, tactical and operational direction and support for working within regulations to expedite the development and delivery of safe and effective healthcare products to individuals around the world.

Why switch your Regulatory operations to LuitBiz?

• Access From Anywhere Anytime: LuitBiz is completely responsive. Your team members can access their it from anywhere, anytime without downloading any mobile or desktop apps
• Complete Document Lifecycle Management: LuitBiz DMS allows you to manage the entire lifecycle of documents from creation to destruction. You can have compltete information about the documents, their versions, their workflows, audit trails etc in just one place
• Integrated "View User" Module: The integrated "View User" module of LuitBiz DMS helps you share documents and TMFs with internal and external study team and customer users for a limited period of time or forever
• Visibility: Real-time dashboards and analytics eliminate spreadsheets & manual reports
• Multiple Business Unit Support: Supports multiple business units that scales as you grow
• Easy-to-use: Extremely easy to use with audio & video guides in each screen. There is no need for your team members to spend long hours trying to learn how to use a software.
• Better Communication Framework: LuitBiz creates a framework for internal communication among employees and provides a basis for the clarification of individual responsibilities

A Regulatory Head plays a critical role in a pharmaceutical company regarding the product lifecycle. He / she develops and executes a regulatory strategy to ensure that the collective efforts of the drug development team results in a product that is not only approvable by global regulators but also differentiated from the competition in some way. The Regulatory Head also ensures that the company’s activities from non-clinical research to advertising and promotion are conducted in accordance with the regulations and guidelines established by regulatory authorities. In order to increase the quality of business output, it is vital to streamline all documentation processes - a job that is taken care of by a Regulatory Head. For performing his / her duties that varies from basic day-to-day administration to decisions that can have a profound effect on the company's identity , performance and strategic direction, the Regulatory Head needs to be equipped with the perfect software tools that will help him / her in performing a better job.

In this regard, LuitBiz DMS gives healthcare companies an edge over their competitors from start to finish of the regulatory process.

The best part about LuitBiz is that you can pick and choose the modules that you require and all of them are already integrated at the back end because, in addition to LuitBiz DMS, it also has the following modules:

• LuitBiz HRM & ESS: For managing your complete employee lifecycle from recruitment till exit
• LuitBiz QMS: For managing your SOPs and their associated forms and checklists for ensuring compliances like ISO, FDA, SEC, GMP, etc.
• LuitBiz BPM: For managing your forms and workflows for streamlining your business processes and workflows
• LuitBiz CRM: For having a birds-eye-view of the entire lifecycle of your customers for up-selling and cross-selling to existing customers and managing your sales pipeline
• LuitBiz EAM: For having complete control over all your assets - movable, immovable and virtual across different business locations located anywhere in the globe

So, there is no additional integration costs. Of course, if you require any customization or integration with your existing systems, we are always ready to do that job for you.

Thus, as a Regulatory Head, you can ensure that all your product registration processes are taken care of in accordance to compliance requirements with LuitBiz.